Exhibit 99.1
Amarin Provides Preliminary 2021 Revenue and Outlook for 2022
DUBLIN, Ireland and BRIDGEWATER, N.J., January 10, 2022 -- Amarin Corporation plc (NASDAQ:AMRN) today provided a business update, including preliminary unaudited full-year 2021 revenue results. Amarin plans to discuss these results and expectations with investors in connection with the 40th Annual J.P. Morgan Healthcare Conference at which Amarin is scheduled to present virtually on Tuesday, January 11, 2022, at 8:15 am Eastern time.
Preliminary (Unaudited) 2021 Financial Results
Revenue Levels: Full-year 2021 total net revenue, subject to audit, are estimated to be approximately $580 million, despite continued impact of global COVID-19 pandemic and generic competition in the United States. Fourth quarter 2021 total revenue is estimated to be approximately $140 million, which is at a similar level as the third quarter of 2021 and stabilizing the 8% decline experienced in Q3 2021 as compared to Q2 2021.
Liquid Assets: Amarin ended 2021 with approximately $490 million in cash and investments, approximately $145 million in net accounts receivable, all of which are current, and with no debt.
Management Commentary
“With the approval of VAZKEPA by EMA at the end of the first quarter of 2021, our expeditious reimbursement dossier submission in ten countries in Europe and the recognition by key cardiovascular societies of the value that icosapent ethyl brings to patients with residual cardiovascular risk, Amarin has the unique opportunity to lead a new paradigm in cardiovascular disease management worldwide,” said Karim Mikhail, Amarin’s president and chief executive officer. “Today, we are also delighted to announce an expansion of our portfolio with our plans to develop a fixed dose combination of VASCEPA® and a statin.”
“Our vision to stop heart disease from being a leading cause of death globally is a large undertaking that motivates us every day to deliver for patients with cardiovascular risk. We remain committed to achieving our goals confident that Amarin has the passion, the science, the strategic planning and the people to realize our vision,” concluded Mr. Mikhail.
Highlights from 2021 and Outlook for 2022
Europe
Highlights of Amarin’s progress in Europe during 2021 include:
Approval of VAZKEPA by the European Commission and the Medicines and Healthcare Products Regulatory Agency as the first and only treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics;
The successful build out of the European commercial organization, which now has 16 legal entities and branches, and a commercial hub in Zug, Switzerland;
Reimbursement discussions proceeding as planned with the submission of market access dossiers in ten European countries namely Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway, and the Netherlands; and
Launch of VAZKEPA in mid-September 2021, which is tracking well relative to other recent cardiometabolic launches, despite the significant, ongoing and resurging COVID-19 disruptions.
1
Amarin’s outlook for achievement in Europe in 2022 includes:
Ongoing education and awareness campaigns across Germany to build market adoption and grow prescriptions for VAZKEPA;
Outcome of market access (reimbursement) decisions in up to eight countries;
The launch of VAZKEPA in up to six countries;
Submission of market access dossiers in an additional five European countries; and
Execution of several agreements in Central and Eastern European markets with partners who already have established infrastructure in such markets.
United States
U.S. commercial highlights from 2021 include:
U.S. product net revenue expected to approximate $575 million in 2021 amidst the ongoing challenges of the COVID-19 pandemic and the impact of two generic icosapent ethyl products;
The U.S. commercial operation continues to operate on a positive contribution margin basis and, along with a strong balance sheet, helps support Amarin’s global growth initiatives; and
Confirmation that the new Go-to-Market strategy has been successfully implemented in the fourth quarter 2021, and is starting to show early results:
oWe have reached more than 150,000 HCPs through our sales force and omnichannel initiatives which are driven by a targeted HCP segmentation strategy and marketing channel optimization;
oAmarin continues to work closely with payers to ensure that VASCEPA maintains a net cost advantage compared to generic icosapent ethyl products. As a result, many payers are covering VASCEPA as the exclusive icosapent ethyl (IPE) product on their formularies. As of December 2021, approximately 40% of total Commercial and Medicare Part D lives estimated to have VASCEPA covered as the exclusive IPE product on a weighted average basis; and
oAmarin has partnered with BlinkRx, a unique patient access solution, to provide an enhanced, digital-first prescription fulfillment channel, that eliminates the challenges for patients in starting and remaining on VASCEPA. Patients benefit from transparent low prices, free home delivery, and world-class support.
U.S. commercial outlook in 2022 is expected to feature:
Continued amplification and expansion of sales force reach through orchestrated omnichannel engagement to enhance customer reach, coverage, share of voice and prescriptions;
Emphasis to all stakeholders that VASCEPA is the only prescription IPE product FDA approved for cardiovascular risk reduction based on the landmark REDUCE-IT trial; and
Consistent effort to grow existing awareness and adoption to ensure VASCEPA revenue in the U.S. is stabilized in the short term, until future life cycle management initiatives deliver their intended growth contribution.
Amarin does not typically comment on ongoing litigation. However, with regards to the District Court’s decision in the Amarin Pharma, Inc. et. al. v. Hikma Pharma, Inc. et. al. matter, we are pleased that the Court found that there exists sufficient basis and factual questions concerning inducement of infringement for the litigation to proceed against Health Net. Amarin will continue to vigorously pursue its case against Health Net. While we are disappointed in the ruling on Hikma’s Motion to Dismiss, we recognize that this is an evolving area of law. Amarin is currently assessing its options, including seeking leave to file an amended complaint or file an appeal of the District Court’s decision. Amarin believes that its patents are being infringed upon and will continue to fight to protect the company’s intellectual property.
2
International
Amarin’s progress toward achieving its goal of expanding the global reach of VASCEPA/VAZKEPA during 2021 was highlighted by:
Acceptance by the Chinese National Medical Products Administration and the Hong Kong Department of Health to review the new drug applications for VASCEPA filed by the company’s partner, Edding;
Development and announcement of an international expansion strategy, through partnerships, that highlights plans to bring the cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to approximately 20 additional countries over the course of the next three years; and
Announcement of VASCEPA co-promotional agreement for Amarin’s partner in Canada, HLS Therapeutics, with Pfizer in Canada.
Outlook and plans for international expansion in 2022 to include:
Final regulatory actions on VASCEPA in Mainland China and in Hong Kong in second half of 2022; and
Regulatory filings, approvals and potential launches of VASCEPA, via partners, in up to six new countries, including Australia, New Zealand, and some Asia-Pacific markets.
Life Cycle Management (LCM)
Highlights of Amarin’s progress in LCM during 2021 and outlook for 2022:
Building on the results of the landmark REDUCE-IT study of VASCEPA on top of statin therapy, the Amarin team dedicated substantial effort in 2021 to exploring opportunities for enhancing our offering to patients in need of reducing their residual cardiovascular risk. As a result of this effort, Amarin has initiated development of a fixed dose combination product that has both icosapent ethyl and a statin. “VASCEPA’s indication for cardiovascular risk reduction provides for the use of the product on top of statin therapy. Our plans to develop and produce a product that has the two components in one has the potential to be a more convenient product for HCPs and patients,” commented Steve Ketchum, Amarin’s executive vice president, president of R&D and chief scientific officer.
New Member of Amarin’s Board of Directors:
We are pleased to announce that Per Wold-Olsen will join the Board of Directors on January 10, 2022, bringing a wealth of global Life Science commercialization and healthcare experience to the Board.
Mr. Wold-Olsen now serves as Chairman of the Board of GN Store Nord A/S, a global top 20 listed Hearing Aid company based in Denmark. He also serves as Chairman of Oncopeptides AB, a Swedish based biotech company. He is past Chairman of Lundbeck A/S, past Chairman of the Medicines for Malaria Ventures, past board member of Gilead Sciences and past board member and now Chair of the Advisory Committee of Novo Holdings - A world leader in Life Science investing.
During his 30-year tenure at Merck & Co. Inc. in Europe and in the US, Mr. Wold-Olsen served as a member of Merck’s Executive Committee between 1994 and 2006. He retired from Merck at the end of 2006 as the President of the Intercontinental Region. At Merck, he was widely seen as the architect of many of the company’s landmark cardiovascular outcome studies - some of the key drivers of Merck’s cardiovascular strategies to demonstrate value, stay competitive and deliver shareholder value.
2022 Financial Outlook
Given the uncertainty primarily related to the continued global impact of COVID-19 as well as the uncertainty resulting from the impact of generic availability in the U.S., Amarin is unable to provide 2022 revenue guidance; however, the company will continue to evaluate its ability to provide as the year progresses.
3
As noted above, U.S. commercial operations are expected to continue to operate on a contribution margin positive basis. Amarin will continue to invest in building the appropriate infrastructure and foundation in Europe for successful commercial launches and advance necessary actions to support regulatory activities in other international markets. Amarin will also progress LCM opportunities as described. The company will continue to evaluate its planned spend in 2022 and adjust if assumptions warrant adjustments.
Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations, including European launch activities.
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our foundation in scientific research to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk.
About Cardiovascular Risk
Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per yeari and the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.ii Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins. iii, iv,v
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.vi The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.vii The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.viii These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance
4
plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United States)
VASCEPA is indicated:
As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
oestablished cardiovascular disease or
odiabetes mellitus and two or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT
5
|
|
|
|
|
|
|
VASCEPA |
Placebo |
VASCEPA
vs Placebo |
N = 4089 n (%) |
Incidence Rate
(per 100 patient years) |
N = 4090 n (%) |
Incidence Rate
(per 100 patient years) |
Hazard Ratio (95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE) |
705 (17.2) |
4.3 |
901 (22.0) |
5.7 |
0.75 (0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point MACE) |
459 (11.2) |
2.7 |
606 (14.8) |
3.7 |
0.74 (0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250 (6.1) |
1.5 |
355 (8.7) |
2.1 |
0.69 (0.58, 0.81) |
Emergent or urgent coronary revascularization |
216 (5.3) |
1.3 |
321 (7.8) |
1.9 |
0.65 (0.55, 0.78) |
Cardiovascular death [1] |
174 (4.3) |
1.0 |
213 (5.2) |
1.2 |
0.80 (0.66, 0.98) |
Hospitalization for unstable angina [2] |
108 (2.6) |
0.6 |
157 (3.8) |
0.9 |
0.68 (0.53, 0.87) |
Fatal or non-fatal stroke |
98 (2.4) |
0.6 |
134 (3.3) |
0.8 |
0.72 (0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. |
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the world-wide market potential for VASCEPA (marketed as VAZKEPA in Europe); expectations regarding financial metrics and performance such as prescription growth, revenue growth, operating expenses, inventory purchases, and managed care coverage for VASCEPA, including the impact of the COVID-19 pandemic, the disappointing outcome of patent litigation and the launch of generic competition on these metrics; beliefs that Amarin is well positioned to deliver on its goals to grow VASCEPA in the U.S. and beyond; beliefs about patient needs for VASCEPA; effects of the COVID-19 pandemic on Amarin's operations and on the healthcare industry more broadly, which effects continue to be fluid; beliefs that Amarin's strategy for reducing the effects of cardiovascular disease is sound and that Amarin is efficiently reaching physicians, payors, pharmacists and patients; plans for Amarin's go-to-market model; the timing and outcome of regulatory reviews, recommendations and
6
approvals and related reimbursement decisions and commercial launches in Europe, the China region and elsewhere; plans for Amarin's expected launch of VAZKEPA directly in major markets in Europe, directly and indirectly; beliefs about the cardioprotective and other benefits of VASCEPA; beliefs about the strength of data in market access dossiers and other reports; expectations for the timing, effectiveness and outcome of promotional activities, including patient-oriented campaigns, conference and posted presentations and education of healthcare professionals; commercial and international expansion, prescription growth and revenue growth and future revenue levels, including the contributions of sales representatives and the new leadership team; beliefs that Amarin's current resources are sufficient to fund projected operations; ongoing patent litigation efforts; and the impact of the COVID-19 pandemic on all of the forgoing. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Amarin's ability to effectively commercialize VASCEPA and maintain or grow market share will depend in part on Amarin’s ability to continue to effectively finance its business, VASCEPA approval in geographies outside the U.S., efforts of third parties, Amarin’s ability to create and increase market demand for VASCEPA through education, marketing and sales activities, to achieve broad market acceptance of VASCEPA, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA and to secure, maintain and defend its patent protection for VASCEPA. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: the possibility that VASCEPA may not receive regulatory approval in the China region or other geographies on the expected timelines or at all, the risk that additional generic versions of VASCEPA will enter the market and that generic versions of VASCEPA will achieve greater market share and more commercial supply than anticipated, particularly in light of the recent and disappointing outcome of Amarin's litigation against two generic drug companies and subsequent requests for appeal; the risk that the scope and duration of the COVID-19 pandemic will continue to impact access to and sales of VASCEPA; the risk that Amarin has overestimated the market potential for VASCEPA in the U.S., Europe and other geographies; risks associated with Amarin's expanded enterprise; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may be determined to not be infringed or not be valid in patent litigation and applications may not result in issued patents sufficient to protect the VASCEPA franchise. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s quarterly report on Form 10-Q for the quarter ended September 30, 2021, filed on or about the date hereof. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact Information
7
Investor Inquiries:
Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
[email protected] (investor inquiries)
Solebury Trout
In U.S.: +1 (646) 378-2992
[email protected]
Media Inquiries: Communications
Amarin Corporation plc
In U.S.: +1 (908) 892-2028
[email protected] (media inquiries)
i American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.
ii Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
iii Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
iv Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
v Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
vi Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
vii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
# # #
8
Investor Presentation JANUARY 2022 a new paradigm in preventative cardiovascular care Exhibit 99.2
Forward Looking Statements & Disclaimer This presentation contains forward-looking statements, such as those relating to the commercial potential of VASCEPA® (VAZKEPA® in Europe), clinical and regulatory efforts and timelines, potential regulatory and pricing approvals, patent litigation, generic product launch, intellectual property, cash flow, research and development, and other statements that are forward-looking in nature and depend upon or refer to future events or conditions, including financial guidance and milestones. These statements involve known and unknown risks, uncertainties and other factors that can cause actual results to differ materially. Investors should not place undue reliance on forward-looking statements, which speak only as of the presentation date of this presentation. Please refer to the “Risk Factors” section in Amarin’s most recent Forms 10-K and 10-Q filed with the SEC and cautionary statements outlined in recent press releases for more complete descriptions of risks in an investment in Amarin. This presentation is intended for communication with investors and not for drug promotion. AMARIN, VASCEPA, VAZKEPA and REDUCE-IT are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.
VISION... ...to stop heart disease from being a leading cause of death For 30 years, the focus has been on lowering LDL cholesterol. Statins have reduced LDL with success and still serve a critical purpose, but they are not the complete solution. Elevated triglycerides are also an important marker to identify cardiovascular risk. A 3 Now is the time to Act on CVD
EVERY 36 SECONDS in the US1 ~60M with CVD in Europe4 523M living with CVD globally6 $1.1tn Estimated economic burden by 20352 €210BN annual spending on CV disease management4 ~18M CVD deaths globally in 20196 44M patients Are projected to be on statins3 >4M People die each year from CVD in the European WHO region5 China alone 290M WITH CVD and the leading cause of death7 US CVD BURDEN EUROPE CVD BURDEN INTERNATIONAL CVD BURDEN Cardiovascular Disease (CVD) Is an Enormous and Worsening Public Health Burden 1 Heart Disease and Stroke Statistics—2021 Update; ACC 2 Cardiovascular Disease: A Costly Burden for America Projections Through 2035; 3 IQVIA, Total Patient Tracker, Statin Projected Patient Counts (USC 32110 HMG-COA REDUCTASE INHIB) 12-months ending November 2021, accessed 1/7/2022; 4 European Heart Network A Blue Print for Action on CVD 2020 5 ESC: Cardiovascular Disease Statistics 2019 6 Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019 7 China Cardiovascular Diseases Report 2018: An Updated Summary On average someone dies of CVD Leading cause of death globally Increasing prevalence High and increasing economic burden
Placebo groups from multiple recent trials show high P-CVR despite statin-based standard-of-care; 14.6% to 34.7% of patients treated for LDL-C, but not for P-CVR, experienced a major adverse cardiovascular event (MACE) in 3-7 Years. Years of follow up All statin-treated patients had well controlled LDL-C levels (ranging from 67-92 mg/dL*) IMPROVE-IT: 34.7% of statin-treated patients had a MACE at 7 years3 REDUCE-IT®: 28.3% of statin-treated patients had a MACE at 5 years2 FOURIER: 14.6% of statin-treated patients had a MACE at 3 years1 Patients with an event, %* 3 5 7 Cross-trial comparisons are subject to differences in populations, primary outcomes, and other trial design aspects 20 10 30 0 Controlled LDL-C doesn’t eliminate CV risk; P-CVR often remains; 25%-35% lowering major adverse CV events (MACE) shown in CV outcome studies of statin therapies. P-CVR – Persistent Cardiovascular Risk LDL-C control 25–35% Lowering LDL-C Helps But is Not Enough for Many Patients Note: FOURIER, REDUCE-IT® and IMPROVE-IT trials evaluated evolocumab, icosapent ethyl and ezetimibe / simvastatin, respectively * 67 mg/dL is equivalent to 0.8 mmol/L and 92 mg/dL is equivalent to 1.0 mmol/L 1. Sabatine MS, et al. N Engl J Med. 2017;376(18):1713-1722; 2. Bhatt DL, et al; for REDUCE-IT® Investigators. N Engl J Med. 2019;380(1):11-22; 3. Cannon CP, et al. N Engl J Med. 2015;372(25):2387-2397 Persistent risk beyond LDL-C control 65–75%
CV drug development: A CHALLENGING endeavor SUCCEEDING in a challenging environment Many biopharma abandoned drug development in CV Requirements for long-term outcomes studies evaluating thousands of patients take years to fulfill With REDUCE-IT®, developed the first and only approved medication for reducing cardiovascular risk beyond LDL lowering therapies in certain high-risk, statin- treated, patients Received an US FDA approval with unanimous Advisory committee positive vote of 16:0 Received European Medicines Agency (EMA) approval for a broad label in-line with the REDUCE-IT evidence Significant costs to fund the commercial infrastructure needed for broad primary care reach 6 AMARIN
VASCEPA/VAZKEPA has Demonstrated CV Risk Reduction Beyond Standard-of-Care (including Statins) in Landmark CVOT HR = hazard ratio; NNT = number needed to treat 1. Bhatt DL et al; for REDUCE-IT® Investigators. N Engl J Med. 2019;380(1):11-22 HR = 0.80 (95% CI, 0.66-0.98) P=0.03 CV Death 20% RRR HR = 0.72 (95% CI, 0.55-0.93) P=0.01 Stroke Fatal/Nonfatal 28% RRR HR = 0.69 (95% CI, 0.58-0.81) P<0.001 MI Fatal/Nonfatal 31% RRR Other Secondary Endpoints HR = 0.74 (95% CI, 0.65-0.83) P=0.0000006 26% RRR NNT=28 Key Secondary Endpoint 3-Point MACE CV death, nonfatal MI, or nonfatal stroke Primary Endpoint 5-Point MACE CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or UA requiring hospitalization HR = 0.75 (95% CI, 0.68-0.83) P=0.00000001 25% RRR NNT=21 RR = 0.70 (95% CI, 0.62-0.78) P=0.00000000036 Total Primary Endpoint Events (first and recurring) Composite of CV death, MI, stroke, coronary revascularization and unstable Angina (UA) 30% RRR Significant reductions across the prespecified testing hierarchy 1 Generally consistent reductions across subgroups Analyses suggest lipid, lipoprotein, and inflammatory markers (including TG) likely have limited contribution to the overall CV benefit demonstrated with icosapent ethyl (IPE) Analysis suggests CV benefit derived from multifactorial effects of icosapent ethyl administered at high levels Well-tolerated safety profile with overall adverse event rates similar for both VASCEPA and placebo patients as per US FDA, Health Canada, and European Commission approved labels for VASCEPA/VAZKEPA and peer-reviewed publication
VASCEPA/VAZKEPA Has the Lowest NNT Among New Therapies Proven to Reduce MACE When Added to Current Standard-of-Care Statin monotherapy On top of statin therapy *Based on primary composite endpoints of each trial Note: Cross-trial comparisons are subject to differences in populations, primary outcomes, study duration and other trial design aspects. Information provided for context only; none of the products have same indication as Vascepa® 1. LaRosa JC, et. al., N Engl J Med 2005;352:1425-35; 2. Cannon CP, et al. N Engl J Med. 2015;372(25):2387-2397; 3. Sabatine MS, et al. N Engl J Med. 2017;376(18):1713-1722; 4. Bhatt DL et al; for REDUCE-IT® Investigators. N Engl J Med. 2019;380(1):11-22 NNT1 45 Lipitor® TNT 2006 4.9 years 22% RRR MACE1 NNT2 50 Zetia® IMPROVE-IT 2015 7.0 years 6% RRR MACE2 NNT3 67 Repatha® FOURIER 2017 2.2 years 15% RRR MACE3 NNT4 Vascepa® (IPE) REDUCE-IT® 2018 4.9 years 21 25% RRR MACE4 NNT: Number of patients who need to be treated to prevent one additional bad outcome Results on left are based on first occurrence of MACE*; VASCEPA/VAZKEPA in total events analysis (first and recurring MACE) resulted on average in 1 fewer MACE per 6 patients treated
VASCEPA/VAZKEPA is a Preventative Cardiovascular (CV) Care Treatment Option Beyond LDL-C Lowering VASCEPA/VAZKEPA is the only drug proven to reduce persistent CV risk in the population studied (P-CVR) Pre-Statin Statin Before 1987 Modest LDL-C or HDL-C 1987 and beyond Aggressive LDL-C “Lower is Better” 2020 and beyond Attacking persistent CV Risk (P-CVR), the risk beyond LDL-C lowering Niacin Statins PCSK-9 Inhibitors Ezetimibe Bempedoic acid Fibrates Bile acid sequestrants
Broad Third-Party Support for Icosapent Ethyl American Association of Clinical Endocrinologists Chinese Society of Cardiology Brazilian Society of Cardiology American College of Endocrinology American College of Cardiology American Diabetes Association American Heart Association American Stroke Association Canadian Cardiovascular Society Committee, in collaboration with the Canadian Stroke Consortium Chinese Journal of Internal Medicine (a journal of the Chinese Medical Association) Canadian Stroke Best Practice Recommendations Advisory Chinese Association of Cardiovascular Surgeons (CACS) Chinese Society of Thoracic and Cardiovascular Surgery (CSTCVS) Diabetes CardioRenal Metabolic Diseases (DCRM) Task Force European Society of Cardiology Egyptian Heart Journal Endocrine Society Colombian Society of Cardiology & Colombian Association of Endocrinology, Diabetes and Metabolism European Association of Preventive Cardiology European Atherosclerosis Society Polish Cardiac Society Working Group on Cardiovascular Pharmacotherapy (SFSN PTK) Japanese Circulation Society Saudi National Diabetes Center 20+ leading medical societies recognizing importance of Icosapent Ethyl: National Lipid Association Thrombosis Canada The Institute for Clinical and Economic Review (ICER) confirms the cost effectiveness of Vascepa across all of the non-profit organization’s analyses, based on its Quality-adjusted life year (QALY) metrics of <$50,000. October 2017
Before 2021; Mostly R&D and US Commercial Focus 2021 and Beyond: Expanding to Europe and International US EUROPE INTERNATIONAL APPROVED Approved for lowering cardiovascular risk (2019) and treating severe hypertriglyceridemia (original niche indication – 2012) APPROVED for lowering cardiovascular risk (2021) Gain access to ~20 ADDITIONAL COUNTRIES to reach the top 50 cardiometabolic markets in the world CANADA: LAUNCHED via partner in 2020 CHINA Submission accepted - anticipated decision in the second half of 2022 MIDDLE EAST: LAUNCHED via distributor in select countries for TG lowering; now pursuing P-CVR indications INITIATING regulatory filing processes for Australia, New Zealand, Israel plus up to 3 others in 2022 10 YEAR regulatory data protection period – no direct competitor LAUNCHED in Germany Sept 2021 Available for private prescribing prior to launch in other EU markets Market access dossiers filed in 10 COUNTRIES FY21 net revenue expected to approximate ~$575 MILLION (unaudited) Limited GENERIC competition Significant Growth Opportunity for VASCEPA/VAZKEPA Launches throughout Europe expected in 2022
Amarin Future Growth Strategy AMARIN
Full Year 2021 Financial Highlights Total full year 2021 revenue, net expected to approximate $580 million (unaudited), compared with $614.1 million in 2020 U.S. VASCEPA retained 80% and 86% of the IPE market, as per Symphony Health data in the three months and eleven months ended November 30, 2021, respectively ~$490 million in cash and investments and no debt Strong balance sheet to support growth and expansion plans Source: Symphony Health Solutions, November, 2021 Amarin Total Revenue by quarter
Amarin go-to-market Expanding Healthcare Provider Engagement: 3-4 X amplification of physicians reach through digital channels Sales force optimization to focus on the most productive and accessible territories Managed Care Access Enhancement: Drive incremental volume growth through further removing barriers to VASCEPA Rx to ensure that patients in need of CV risk reduction receive proper therapy Optimizing VASCEPA Prescriptions for CV Risk Reduction: Address gaps in prescribing ecosystem to reduce inappropriate generic substitution Evaluating various innovative solutions designed to better manage IPE Rx for CVRR 1 2 3 reached > 150,000 HCPs Via Omnichannel 40% of total Commercial & Medicare Part D lives1 have VASCEPA as the partnered with BlinkRx providing an enhanced, digital-first prescription fulfilment channel, that eliminates the challenges for patients in starting and remaining on VASCEPA 1. As of December 2021 and on weighted average basis 14 AMARIN STRATEGYto drive growth in the US exclusive IPE product
Early signals of the impact of our new Go-To-Market Strategy New to Brand (NTB) growth being led by Branded VASCEPA– Up 8% in recent 4 weeks reaching pre-generic level – Total IPE up 5% Cardiology, Primary Care and Endocrinology all contributing to NTB growth Importantly, Cardiology showing consistent growth up 12% in recent 4 weeks VASCEPA New to Brand Rx Source: Symphony Prescriber Source Data, WE 12/17/2021 NTB: Patients with first fill in 12-months time period for product. 15
VAZKEPA in Europe December 2020 Regulatory approval No Reimbursement None Infrastructure None Medical Education Limited Supply Chain Solid manufacturing network & 3PL agreement Marketing Strategy Initial Planning Team Recruitment of core team ~10 December 2021 EMA & MHRA 10 market dossiers submitted On-going constructive discussions with all health authorities EU commercial hub established in Zug, Switzerland Key financial, legal and compliance processes in place Medical Directors and MSL driving significant medical education programs across Europe, with the most influential national and European opinion leaders Signed contracts with wholesalers in Germany, UK, Italy & the Nordics Go to market strategy, content engine, digital capabilities and CRM foundations ready for 2022 launches ~ 250 Associates ACHIEVEMENTS AMARIN 16
Europe Outlook 2022: Filed market access dossiers in ten key EU countries ahead of YE schedule Reimbursement decisions expected in up to 8 countries The launch of VAZKEPA in up to 6 countries Plans to file next wave of five market access dossiers in 2022 Execution of several agreements in Central & Eastern European markets with partners who already have established infrastructure in such markets 4M deaths per year in Europe WHO ~€210B annual CVD costs to European Union2 10+years of market exclusivity in Europe ESC: Cardiovascular Disease Statistics 2019 European Heart Network. European Cardiovascular Disease Statistics 2017. https://ehnheart.org/cvd-statistics/cvd-statistics-2017.html. Accessed January 2022 Significant Market Opportunity region due to CVD1
Launched VAZKEPA in Germany Relentless focus on education, awareness & access World class scientific launch, scientific media resonance and recognition (Galenus von Pergamon prize finalist) Short Pre-Launch and Covid resurgence, leading to an average frequency of 2.6 in our targeted doctors VAZKEPA volume uptake benchmark comparable to other CV medicines recently launched* Note : Spec Field Force in field since Feb 21, and PCP since Apr 21 *Note : Normalized volume uptake curves relative to peak year sales of the Analogs to ensure comparability Standard Packs
Partnering to Unlock Revenue Potential in ~20 Additional Markets Internationally EU US sNDA Approved Dec. 20191,2 China / HK MENA Approved in Lebanon (Mar. 2018), UAE (Jul. 2018), Qatar (Jan. 2020), Bahrain (Nov. 2020) Mexico Russia Australia Brazil Japan India Direct launch Partnered Unpartnered3 ROW (select regions with significant opportunity highlighted) 1 For cardiovascular risk reduction indication; 2 For severe hypertriglyceridemia indication; original U.S. NDA approval in July 2012; Canada NDS Approved1 Dec. 2019 EC Approved April 2021
Note: The company is pursuing expansion into these various additional markets and the status of regulatory and/or patent approval will vary between market to market. Plans to Bring Unique Cardioprotective Benefits of VASCEPA/VAZKEPA to 20 Additional Markets 1st Wave 2022 2nd Wave 2023 Supported by REDUCE-IT Study and U.S. FDA and EMA Filings 3rd Wave 2024 6 9 5 Countries Countries Countries Seeking Partnerships in approximately 20 additional Countries Representing Potential ~$1B Opportunity AMARIN
VASCEPA/VAZKEPA Life Cycle Management Progress AS A RESULT OF THE LCM EFFORT to enhance our offering to patient in need of reducing their Cardiovascular Risk And in-line with our cardiovascular outcome label where icosapent ethyl is used on top of a statin AMARIN IS INITIATING the development of a fixed dose combination product that has the two components in one
Amarin Strengthens its Executive and Board Leadership: 4 New Executive Members Laurent Abuaf Senior Vice President & President of Europe August 2021 Jason Marks Chief Legal Officer & Corporate Secretary August 2021 Alan Wills Executive Vice President Corporate Business Development November 2021 Lisa DeFrancesco Senior Vice President Investor Relations February 2022 New Board Member Per Wold-Olsen Board Member January 2022
Amarin: An Exciting Opportunity to Create Value US EUROPE FUTURE INTERNATIONAL Grow and defend VASCEPA despite generics’ presence on the market for the VHTG indication Advance the Go-to-Market digital omnichannel model to drive greater awareness and demand Development of fixed dose combination – icosapent ethyl and a statin Build awareness of VAZKEPA across EU as we prepare for strong sequenced launches in key markets throughout 2022 Value based proposed list price of ~€200 or $240 monthly Regulatory filings, approvals and potential launches of VASCEPA, via partners, in up to six new countries, including Australia, New Zealand, and some Asia-Pacific markets Final regulatory actions on VASCEPA in Mainland China and in Hong Kong in second half of 2022 Seek partnerships and opportunities to leverage growing global commercial infrastructure and competent R&D team
Investor Presentation JANUARY 2022